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FDA 510(k)

PERIMETER Interbody Fusion Device

K-Number: K160418 · 2016-03-07

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-03-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERIMETER Interbody Fusion Device is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-03-07 under approval number K160418. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIMETER Interbody Fusion Device?

PERIMETER Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2016-03-07. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K160418.

When was PERIMETER Interbody Fusion Device approved by the FDA?

PERIMETER Interbody Fusion Device received FDA 510(k) clearance on 2016-03-07, under approval number K160418.

What company makes PERIMETER Interbody Fusion Device?

PERIMETER Interbody Fusion Device is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for PERIMETER Interbody Fusion Device?

The FDA product code for PERIMETER Interbody Fusion Device is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Medtronic Sofamor Danek USA, Inc.

K163301CD HORIZON® Spinal System K162680SOVEREIGN® Spinal System K162379CD HORIZON® Spinal System K162494CD HORIZON® Spinal System K160528ANATOMIC PEEK PTC Cervical Fusion System K153438PERIMETER C (Titanium) Spinal System

View all 76 devices →

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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